Full Press Release Details
– 14% year-over-year revenue increase from combined key growth drivers: Xywav ® , Epidiolex ® and Rylaze ® – – 2024 total revenue guidance affirmed at $4.0 to $4.1 billion – – Zanidatamab 2L BTC PDUFA date of November 29, 2024 – – Plan to submit sNDA for Zepzelca ® in 1L ES-SCLC in 1H25 –
DUBLIN , Nov. 6, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ ) today announced financial results for the third quarter of 2024 and updated guidance for 2024.
"Jazz once again delivered record revenues of more than $1.05 billion and a 14% year-over-year increase in revenue from our key growth drivers combined. We continue to see robust patient demand for Xywav with approximately 400 net patient additions in the third quarter, supported by physician and patient appreciation of a low-sodium treatment option. Strong sleep 1 performance coupled with continued Epidiolex performance gives us confidence in maintaining our total revenue guidance of $4.0 to $4.1 billion for 2024," said Bruce Cozadd , chairman and chief executive officer, Jazz Pharmaceuticals. "We're preparing for the anticipated launch of zanidatamab in the fourth quarter in 2L BTC, where there remains a high unmet medical need. We expect to provide the first chemotherapy-free dual HER2-targeted bispecific antibody indicated for BTC as well as an opportunity for HCPs to gain important experience ahead of future indications. In addition, results from the Phase 3 IMforte trial were highly encouraging, and we plan to submit an sNDA for Zepzelca in the first half of 2025 to support expansion into the 1L maintenance setting in ES-SCLC."
| 1 | Total Sleep revenue includes: Xywav, branded Xyrem and high-sodium oxybate authorized generic royalty revenues. |
| 2 | See "Non-GAAP Financial Measures." |
Business Updates
Commercial Updates
Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution:
Xyrem ® (sodium oxybate) oral solution and high-sodium oxybate authorized generic (AG) royalties:
Epidiolex / Epidyolex (cannabidiol):
Rylaze / Enrylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn):
Zepzelca (lurbinectedin):
Key Pipeline Highlights
Senior Notes Offering and Concurrent Share Repurchases In the third quarter of 2024, the Company completed a private placement of $1.0 billion aggregate principal amount of 3.125% exchangeable senior notes due 2030, or 2030 Notes. The Company intends to use a portion of the proceeds from the private placement to make a payment on the Term Loan B following the mid-January 2025 expiration of the 1% prepayment premium period in place after the recent repricing. Concurrently with this transaction, the Company repurchased approximately $150.0 million of its ordinary shares. The Company paid for such repurchases with existing cash on hand, and such share repurchases were effected as part of the Company's share repurchase program announced in July 2024 .
Financial Highlights
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||
| (In thousands, except per share amounts) | 2024 | 2023 | 2024 | 2023 | |||
| Total revenues | $ 1,054,969 | $ 972,140 | $ 2,980,777 | $ 2,822,269 | |||
| GAAP net income | $ 215,055 | $ 146,820 | $ 369,005 | $ 320,678 | |||
| Non-GAAP adjusted net income | $ 416,924 | $ 340,148 | $ 963,866 | $ 950,538 | |||
| GAAP earnings per share | $ 3.42 | $ 2.14 | $ 5.63 | $ 4.67 | |||
| Non-GAAP adjusted EPS | $ 6.61 | $ 4.84 | $ 14.42 | $ 13.29 |
GAAP net income for 3Q24 was $215 .1 million, or $3.42 per diluted share, compared to $146 .8 million, or $2.14 per diluted share, for 3Q23.
Non-GAAP adjusted net income for 3Q24 was $416 .9 million, or $6.61 per diluted share, compared to $340 .1 million, or $4.84 per diluted share, for 3Q23.
Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release.
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||
| (In thousands) | 2024 | 2023 | 2024 | 2023 | |||
| Xywav | $ 388,466 | $ 331,633 | $ 1,072,238 | $ 935,958 | |||
| Xyrem | 58,114 | 125,110 | 184,526 | 463,009 | |||
| Epidiolex/Epidyolex | 251,558 | 213,711 | 697,376 | 604,846 | |||
| Sativex | 4,586 | 4,627 | 13,704 | 14,531 | |||
| Total Neuroscience | 702,724 | 675,081 | 1,967,844 | 2,018,344 | |||
| Rylaze/Enrylaze | 98,780 | 104,859 | 309,359 | 292,479 | |||
| Zepzelca | 85,843 | 77,994 | 241,990 | 215,523 | |||
| Defitelio/defibrotide | 65,818 | 47,730 | 158,915 | 132,917 | |||
| Vyxeos | 34,313 | 29,827 | 109,348 | 100,583 | |||
| Total Oncology | 284,754 | 260,410 | 819,612 | 741,502 | |||
| Other | 2,229 | 2,907 | 8,497 | 9,758 | |||
| Product sales, net | 989,707 | 938,398 | 2,795,953 | 2,769,604 | |||
| High-sodium oxybate AG royalty revenue | 58,157 | 28,921 | 162,268 | 36,531 | |||
| Other royalty and contract revenues | 7,105 | 4,821 | 22,556 | 16,134 | |||
| Total revenues | $ 1,054,969 | $ 972,140 | $ 2,980,777 | $ 2,822,269 |
Total revenues increased 9% in 3Q24 compared to the same period in 2023.
Total neuroscience revenue, including high-sodium oxybate AG royalty revenue, was $760 .9 million in 3Q24, an increase of 8% compared to $704 .0 million in 3Q23, primarily due to increased Xywav and Epidiolex/Epidyolex net product sales and increased high-sodium oxybate AG royalty revenue partially offset by decreased Xyrem revenues.
Oncology net product sales were $284 .8 million in 3Q24, an increase of 9% compared to the same period in 2023, and included higher net product sales from Defitelio/defibrotide which increased 38% to $65 .8 million primarily due to timing of orders and Zepzelca which increased 10% to $85.8 million . In 3Q24, Rylaze net product sales were negatively affected by a recent update to pediatric ALL protocols regarding timing of asparaginase administration.
Operating Expenses and Effective Tax Rate
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||
| (In thousands, except percentages) | 2024 | 2023 | 2024 | 2023 | |||
| GAAP: | |||||||
| Cost of product sales | $ 111,611 | $ 102,153 | $ 317,000 | $ 328,334 | |||
| Gross margin | 88.7 % | 89.1 % | 88.7 % | 88.1 % | |||
| Selling, general and administrative | $ 325,772 | $ 308,310 | $ 1,016,007 | $ 947,071 | |||
| % of total revenues | 30.9 % | 31.7 % | 34.1 % | 33.6 % | |||
| Research and development | $ 199,919 | $ 234,402 | $ 643,500 | $ 633,050 | |||
| % of total revenues | 19.0 % | 24.1 % | 21.6 % | 22.4 % | |||
| Acquired in-process research and development | $ — | $ — | $ 10,000 | $ 1,000 | |||
| Income tax benefit 1 | $ (14,533) | $ (47,176) | $ (33,517) | $ (86,823) | |||
| Effective tax rate 1 | (7.2) % | (47.4) % | (9.9) % | (36.7) % |
_________________________
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||
| (In thousands, except percentages) | 2024 | 2023 | 2024 | 2023 | |||
| Non-GAAP adjusted: | |||||||
| Cost of product sales | $ 72,844 | $ 67,119 | $ 209,405 | $ 197,841 | |||
| Gross margin | 92.6 % | 92.8 % | 92.5 % | 92.9 % | |||
| Selling, general and administrative | $ 288,672 | $ 273,042 | $ 903,557 | $ 810,428 | |||
| % of total revenues | 27.4 % | 28.1 % | 30.3 % | 28.7 % | |||
| Research and development | $ 180,992 | $ 217,767 | $ 588,470 | $ 583,704 | |||
| % of total revenues | 17.2 % | 22.4 % | 19.7 % | 20.7 % | |||
| Acquired in-process research and development | $ — | $ — | $ 10,000 | $ 1,000 | |||
| Income tax expense 1 | $ 41,683 | $ 7,378 | $ 130,999 | $ 72,785 | |||
| Effective tax rate 1 | 9.1 % | 2.1 % | 11.9 % | 7.1 % |
_________________________
Changes in operating expenses in 3Q24 over the prior year period are primarily due to the following:
Cash Flow and Balance Sheet As of September 30, 2024, cash, cash equivalents and investments were $2 .6 billion, and the outstanding principal balance of the Company's long-term debt was $6 .2 billion. In addition, the Company had undrawn borrowing capacity under a revolving credit facility of $500.0 million . In 3Q24, we repaid the $575.0 million aggregate principal amount of the 1.50% exchangeable senior notes due 2024, or 2024 Notes, and completed the private placement of the 2030 Notes. For the nine months ended September 30, 2024, the Company generated $997 .3 million of cash from operations reflecting strong business performance and continued financial discipline.
2024 Financial Guidance The Company is updating its full year 2024 financial guidance as follows:
| (In millions) | November 6, 2024 | July 31, 2024 | |
| Revenues | $4,000 - $4,100 | $4,000 - $4,100 | |
| –Neuroscience (includes royalties from high-sodium oxybate AG) | $2,825 - $2,925 | $2,825 - $2,925 | |
| –Oncology | $1,080 - $1,130 | $1,100 - $1,150 |
| (In millions, except per share amounts and percentages) | November 6, 2024 | July 31, 2024 | |
| Gross margin % | 89 % | 89 % | |
| SG&A expenses | $1,339 - $1,392 | $1,366 - $1,426 | |
| SG&A expenses as % of total revenues | 33% - 35% | 33% - 36% | |
| R&D expenses | $862 - $908 | $887 - $935 | |
| R&D expenses as % of total revenues | 21% - 23% | 22% - 23% | |
| Effective tax rate | (17)% - (2)% | (22)% - (3)% | |
| Net income | $430 - $550 | $385 - $530 | |
| Net income per diluted share 5 | $6.70 - $8.50 | $6.00 - $8.00 | |
| Weighted-average ordinary shares used in per share calculations | 66 | 67 |
| (In millions, except per share amounts and percentages) | November 6, 2024 | July 31, 2024 | |
| Gross margin % | 93% 1,6 | 93 % | |
| SG&A expenses | $1,190 - $1,230 2,6 | $1,190 - $1,230 | |
| SG&A expenses as % of total revenues | 29% - 31% | 29% - 31% | |
| R&D expenses | $790 - $830 3,6 | $810 - $850 | |
| R&D expenses as % of total revenues | 19% - 21% | 20% - 21% | |
| Effective tax rate | 10% - 12% 4,6 | 10% - 12% | |
| Net income | $1,275 - $1,350 6 | $1,275 - $1,350 | |
| Net income per diluted share 5 | $19.50 - $20.60 6 | $19.20 - $20.30 | |
| Weighted-average ordinary shares used in per share calculations | 66 | 67 |
___________________________
| 1. | Excludes $125-$145 million of amortization of acquisition-related inventory fair value step-up and $14-$15 million of share-based compensation expense. |
| 2. | Excludes $149-$162 million of share-based compensation expense. |
| 3. | Excludes $72-$78 million of share-based compensation expense. |
| 4. | Excludes 27%-14% from the GAAP effective tax rate of (17)%-(2)% relating to the income tax effect of adjustments between GAAP net income and non-GAAP adjusted net income, resulting in a non-GAAP adjusted effective tax rate of 10%-12%. |
| 5. | Diluted EPS calculations for 2024 include an estimated 3.5 million shares related to the assumed conversion of the 2.000% exchangeable senior notes due 2026, or the 2026 Notes, and the associated interest expense, net of tax, add-back to net income of $11 million and $10 million, on a GAAP and on a non-GAAP adjusted basis, respectively, under the "if converted" method. In July 2024, we made the irrevocable election to net share settle the 2026 Notes. This election is expected to increase our full-year net income per diluted share guidance by $0.15 to $0.25 per share, on a GAAP basis, and $0.70 to $0.75 per share, on a non-GAAP adjusted basis, as a result of an estimated decrease in the weighted-average outstanding shares of 2.9 million shares. |
| 6. | See "Non-GAAP Financial Measures" below. Reconciliations of non-GAAP adjusted guidance measures are included above and in the table titled "Reconciliation of GAAP to non-GAAP Adjusted 2024 Net Income Guidance" at the end of this press release. |
Conference Call Details
Jazz Pharmaceuticals will host an investor conference call and live audio webcast today at 4:30 p.m. ET ( 9:30 p.m. GMT ) to provide a business and financial update and discuss its 2024 third quarter results.
Audio webcast/conference call: U.S. Dial-In Number: +1 800 715 9871 Ireland Dial-In Number: +353 1800 943 926 Additional global dial-in numbers are available here . Passcode: 5080203
Interested parties may access the live audio webcast via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com . To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast.
A replay of the webcast will be available via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com .
About Jazz Pharmaceuticals
Jazz Pharmaceuticals plc (NASDAQ: JAZZ ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.
Non-GAAP Financial Measures
To supplement Jazz Pharmaceuticals' financial results and guidance presented in accordance with U.S. generally accepted accounting principles (GAAP), the Company uses certain non-GAAP (also referred to as adjusted or non-GAAP adjusted) financial measures in this press release and the accompanying tables. In particular, the Company presents non-GAAP adjusted net income (and the related per share measure) and its line-item components, as well as certain non-GAAP adjusted financial measures derived therefrom, including non-GAAP adjusted gross margin percentage and non-GAAP adjusted effective tax rate. Non-GAAP adjusted net income (and the related per share measure) and its line-item components exclude from GAAP reported net income (and the related per share measure) and its line-item components certain items, as detailed in the reconciliation tables that follow, and in the case of non-GAAP adjusted net income (and the related per share measure), adjust for the income tax effect of the non-GAAP adjustments. In this regard, the components of non-GAAP adjusted net income, including non-GAAP adjusted cost of product sales, SG&A expenses and R&D expenses, are income statement line items prepared on the same basis as, and therefore components of, the overall non-GAAP adjusted net income measure.
Caution Concerning Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to: the Company's growth prospects and future financial and operating results, including the Company's 2024 financial guidance and the Company's expectations related thereto and anticipated catalysts; expectations that Xywav will remain the oxybate of choice; expectations of high-sodium oxybate AG royalty revenue in 2024; the ability to generate long-term sustainable growth and value; the Company's advancement of pipeline programs and the timing of development activities, regulatory activities and submissions related thereto, including plans to submit a sNDA for Zepzelca in 1L ES-SCLC in the first half of 2025 and the anticipated launch of zanidatamab in 2L BTC; planned or anticipated clinical trial events, including with respect to initiations, enrollment and data read-outs, and the anticipated timing thereof, including: top-line PFS data from a Phase 3 trial of zanidatamab in 1L GEA, plans to initiate a Phase 1b trial of JZP441 in type 1 narcolepsy patients; and the Company's development, regulatory and commercialization strategy, including the Company's expectations to executing multiple Epidyolex launches through 2024; the Company's expectations with respect to its products and product candidates and the potential of the Company's products and product candidates and the potential regulatory path related thereto; the Company's capital allocation and corporate development strategy; the potential successful future development, manufacturing, regulatory and commercialization activities; the Company's ability to realize the commercial potential of its products; the Company's net product sales and goals for net product sales from new and acquired products; the Company's views and expectations relating to its patent portfolio, including with respect to expected patent protection, as well as expectations with respect to exclusivity; the Company's clinical trials confirming clinical benefit or enabling regulatory submissions; planned or anticipated regulatory submissions and filings, and the anticipated timing thereof; potential regulatory approvals; and other statements that are not historical facts. These forward-looking statements are based on the Company's current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties.
Actual results and the timing of events could differ materially from those anticipated in such forward- looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with: maintaining or increasing sales of, and revenue from, Xywav, Rylaze and Epidiolex/Epidyolex and other marketed products; the introduction of new products into the U.S. market that compete with, or otherwise disrupt the market for the Company's products and product candidates; effectively launching and commercializing the Company's other products and product candidates; the successful completion of development and regulatory activities with respect to the Company's product candidates, obtaining and maintaining adequate coverage and reimbursement for the Company's products; the time-consuming and uncertain regulatory approval process, including the risk that the Company's current and/or planned regulatory submissions may not be submitted, accepted or approved by applicable regulatory authorities in a timely manner or at all; the costly and time-consuming pharmaceutical product development and the uncertainty of clinical success, including risks related to failure or delays in successfully initiating or completing clinical trials and assessing patients; global economic, financial, and healthcare system disruptions and the current and potential future negative impacts to the Company's business operations and financial results; geopolitical events, including the conflict between Russia and Ukraine and related sanctions; macroeconomic conditions, including global financial markets, rising interest rates and inflation and recent and potential banking disruptions; regulatory initiatives and changes in tax laws; market volatility; protecting and enhancing the Company's intellectual property rights and the Company's commercial success being dependent upon the Company obtaining, maintaining and defending intellectual property protection and exclusivity for its products and product candidates; delays or problems in the supply or manufacture of the Company's products and product candidates; complying with applicable U.S. and non-U.S. regulatory requirements, including those governing the research, development, manufacturing and distribution of controlled substances; government investigations, legal proceedings and other actions; identifying and consummating corporate development transactions, financing these transactions and successfully integrating acquired product candidates, products and businesses; the Company's ability to realize the anticipated benefits of its corporate development transactions and its collaborations and license agreements with third parties; the sufficiency of the Company's cash flows and capital resources; the Company's ability to achieve targeted or expected future financial performance and results and the uncertainty of future tax, accounting and other provisions and estimates; the Company's ability to meet its projected long-term goals and objectives, in the time periods that the Company anticipates, or at all, and the inherent uncertainty and significant judgments and assumptions underlying the Company's long-term goals and objectives; fluctuations in the market price and trading volume of the Company's ordinary shares; the timing and availability of alternative investment opportunities; and other risks and uncertainties affecting the Company, including those described from time to time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals' Securities and Exchange Commission filings and reports, including the Company's Annual Report on Form 10-K for the year ended December 31, 2023 , as supplemented by our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 , and future filings and reports by the Company. Other risks and uncertainties of which the Company is not currently aware may also affect the Company's forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated.
| JAZZ PHARMACEUTICALS PLC | |||||||
| CONDENSED CONSOLIDATED STATEMENTS OF INCOME | |||||||
| (In thousands, except per share amounts) | |||||||
| (Unaudited) | |||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||
| 2024 | 2023 | 2024 | 2023 | ||||
| Revenues: | |||||||
| Product sales, net | $ 989,707 | $ 938,398 | $ 2,795,953 | $ 2,769,604 | |||
| Royalties and contract revenues | 65,262 | 33,742 | 184,824 | 52,665 | |||
| Total revenues | 1,054,969 | 972,140 | 2,980,777 | 2,822,269 | |||
| Operating expenses: | |||||||
| Cost of product sales (excluding amortization of acquired developed technologies) | 111,611 | 102,153 | 317,000 | 328,334 | |||
| Selling, general and administrative | 325,772 | 308,310 | 1,016,007 | 947,071 | |||
| Research and development | 199,919 | 234,402 | 643,500 | 633,050 | |||
| Intangible asset amortization | 157,457 | 154,883 | 468,410 | 456,731 | |||
| Acquired in-process research and development | — | — | 10,000 | 1,000 | |||
| Total operating expenses | 794,759 | 799,748 | 2,454,917 | 2,366,186 | |||
| Income from operations | 260,210 | 172,392 | 525,860 | 456,083 | |||
| Interest expense, net | (58,702) | (71,497) | (186,841) | (219,114) | |||
| Foreign exchange loss | (701) | (1,377) | (1,887) | (566) | |||
| Income before income tax benefit and equity in loss (gain) of investees | 200,807 | 99,518 | 337,132 | 236,403 | |||
| Income tax benefit | (14,533) | (47,176) | (33,517) | (86,823) | |||
| Equity in loss (gain) of investees | 285 | (126) | 1,644 | 2,548 | |||
| Net income | $ 215,055 | $ 146,820 | $ 369,005 | $ 320,678 | |||
| Net income per ordinary share: | |||||||
| Basic | $ 3.50 | $ 2.33 | $ 5.93 | $ 5.05 | |||
| Diluted | $ 3.42 | $ 2.14 | $ 5.63 | $ 4.67 | |||
| Weighted-average ordinary shares used in per share calculations - basic | 61,414 | 63,114 | 62,275 | 63,532 | |||
| Weighted-average ordinary shares used in per share calculations - diluted | 63,174 | 71,293 | 67,511 | 72,866 |
| JAZZ PHARMACEUTICALS PLC | |||
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||
| (In thousands) | |||
| (Unaudited) | |||
| September 30, 2024 | December 31, 2023 | ||
| ASSETS | |||
| Current assets: | |||
| Cash and cash equivalents | $ 2,218,135 | $ 1,506,310 | |
| Investments | 400,000 | 120,000 | |
| Accounts receivable, net of allowances | 723,639 | 705,794 | |
| Inventories | 539,302 | 597,039 | |
| Prepaid expenses | 155,132 | 185,476 | |
| Other current assets | 354,215 | 320,809 | |
| Total current assets | 4,390,423 | 3,435,428 | |
| Property, plant and equipment, net | 176,422 | 169,646 | |
| Operating lease assets | 77,164 | 65,340 | |
| Intangible assets, net | 5,144,217 | 5,418,039 | |
| Goodwill | 1,804,646 | 1,753,130 | |
| Deferred tax assets, net | 583,218 | 477,834 | |
| Deferred financing costs | 4,395 | 6,478 | |
| Other non-current assets | 75,231 | 67,464 | |
| Total assets | $ 12,255,716 | $ 11,393,359 | |
| LIABILITIES AND SHAREHOLDERS' EQUITY | |||
| Current liabilities: | |||
| Accounts payable | $ 85,425 | $ 102,750 | |
| Accrued liabilities | 858,578 | 793,914 | |
| Current portion of long-term debt | 31,000 | 604,954 | |
| Income taxes payable | 54,974 | 35,074 | |
| Total current liabilities | 1,029,977 | 1,536,692 | |
| Long-term debt, less current portion | 6,080,802 | 5,107,988 | |
| Operating lease liabilities, less current portion | 71,115 | 59,225 | |
| Deferred tax liabilities, net | 791,784 | 847,706 | |
| Other non-current liabilities | 110,971 | 104,751 | |
| Total shareholders' equity | 4,171,067 | 3,736,997 | |
| Total liabilities and shareholders' equity | $ 12,255,716 | $ 11,393,359 |
| JAZZ PHARMACEUTICALS PLC | |||
| SUMMARY OF CASH FLOWS | |||
| (In thousands) | |||
| (Unaudited) | |||
| Nine Months Ended September 30, | |||
| 2024 | 2023 | ||
| Net cash provided by operating activities | $ 997,328 | $ 924,668 | |
| Net cash used in investing activities | (314,908) | (264,860) | |
| Net cash provided by (used in) financing activities | 28,791 | (204,948) | |
| Effect of exchange rates on cash and cash equivalents | 614 | (652) | |
| Net increase in cash and cash equivalents | $ 711,825 | $ 454,208 |
| JAZZ PHARMACEUTICALS PLC | |||||||||||||||
| RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION | |||||||||||||||
| (In thousands, except per share amounts) | |||||||||||||||
| (Unaudited) | |||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Net Income | Diluted EPS 1 | Net Income | Diluted EPS 1 | Net Income | Diluted EPS 1 | Net Income | Diluted EPS 1 | ||||||||
| GAAP reported | $ 215,055 | $ 3.42 | $ 146,820 | $ 2.14 | $ 369,005 | $ 5.63 | $ 320,678 | $ 4.67 | |||||||
| Intangible asset amortization | 157,457 | 2.49 | 154,883 | 2.17 | 468,410 | 6.94 | 456,731 | 6.27 | |||||||
| Share-based compensation expense | 59,760 | 0.95 | 56,115 | 0.79 | 177,855 | 2.63 | 173,900 | 2.39 | |||||||
| Acquisition accounting inventory fair value step-up | 35,034 | 0.55 | 30,822 | 0.43 | 97,220 | 1.44 | 119,094 | 1.63 | |||||||
| Other costs 2 | — | — | — | — | — | — | 23,488 | 0.32 | |||||||
| Non-cash interest expense 3 | 5,834 | 0.09 | 6,062 | 0.09 | 15,892 | 0.24 | 16,255 | 0.23 | |||||||
| Income tax effect of above adjustments | (56,216) | (0.89) | (54,554) | (0.77) | (164,516) | (2.44) | (159,608) | (2.19) | |||||||
| Effect of assumed conversion of Exchangeable Senior Notes 1 | — | — | — | (0.01) | — | (0.02) | — | (0.03) | |||||||
| Non-GAAP adjusted | $ 416,924 | $ 6.61 | $ 340,148 | $ 4.84 | $ 963,866 | $ 14.42 | $ 950,538 | $ 13.29 | |||||||
| Weighted-average ordinary shares used in diluted per share calculations - GAAP and non-GAAP 1 | 63,174 | 71,293 | 67,511 | 72,866 |
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| Explanation of Adjustments and Certain Line Items: | |
| 1. | Diluted EPS was calculated using the "if-converted" method in relation to the 2024 Notes and the 2026 Notes, which we refer to collectively as the Exchangeable Senior Notes. In August 2023 and July 2024, we made irrevocable elections to net share settle the 2024 Notes and the 2026 Notes, respectively. As a result, the assumed issuance of ordinary shares upon exchange of the Exchangeable Senior Notes has only been included in the calculation of diluted net income per ordinary share, on a GAAP and on a non-GAAP adjusted basis, in each period up to the date each irrevocable election was made. Net income per diluted share, on a GAAP and a non-GAAP adjusted basis, for the three and nine months ended September 30, 2024 included 1.3 million shares and 4.7 million shares, respectively, related to the assumed conversion of the 2026 Notes and the associated interest expense, net of tax, add-back to GAAP reported net income of $1.0 million and $10.8 million, respectively, and the associated interest expense, net of tax, add-back to non-GAAP adjusted net income of $0.9 million and $9.7 million, respectively. Net income per diluted share, on a GAAP and on a non-GAAP adjusted basis, for the three and nine months ended September 30, 2023 included 7.6 million shares and 8.5 million shares, respectively, related to the assumed conversion of the Exchangeable Senior Notes and the associated interest expense, net of tax, add-back to GAAP reported net income of $5.9 million and $20.0 million, respectively, and the associated interest expense, net of tax, add-back to non-GAAP adjusted net income of $5.2 million and $17.8 million, respectively. |
| 2. | Costs related to program terminations. |
| 3. | Non-cash interest expense associated with debt issuance costs. |
| JAZZ PHARMACEUTICALS PLC | |||||||||||||
| RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION | |||||||||||||
| CERTAIN LINE ITEMS - FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2024 AND 2023 | |||||||||||||
| (In thousands, except percentages) | |||||||||||||
| (Unaudited) | |||||||||||||
| Three months ended September 30, 2024 | |||||||||||||
| Cost of product sales | Gross margin | Selling, general and administrative | Research and development | Intangible asset amortization | Interest expense, net | Income tax expense (benefit) | |||||||
| GAAP Reported | $ 111,611 | 88.7 % | $ 325,772 | $ 199,919 | $ 157,457 | $ 58,702 | $ (14,533) | ||||||
| Non-GAAP Adjustments: | |||||||||||||
| Intangible asset amortization | — | — | — | — | (157,457) | — | — | ||||||
| Share-based compensation expense | (3,733) | 0.4 | (37,100) | (18,927) | — | — | — | ||||||
| Acquisition accounting inventory fair value step-up | (35,034) | 3.5 | — | — | — | — | — | ||||||
| Non-cash interest expense | — | — | — | — | — | (5,834) | — | ||||||
| Income tax effect of above adjustments | — | — | — | — | — | — | 56,216 | ||||||
| Total of non-GAAP adjustments | (38,767) | 3.9 | (37,100) | (18,927) | (157,457) | (5,834) | 56,216 | ||||||
| Non-GAAP Adjusted | $ 72,844 | 92.6 % | $ 288,672 | $ 180,992 | $ — | $ 52,868 | $ 41,683 | ||||||
| Three months ended September 30, 2023 | |||||||||||||
| Cost of product sales | Gross margin | Selling, general and administrative | Research and development | Intangible asset amortization | Interest expense, net | Income tax expense (benefit) | |||||||
| GAAP Reported | $ 102,153 | 89.1 % | $ 308,310 | $ 234,402 | $ 154,883 | $ 71,497 | $ (47,176) | ||||||
| Non-GAAP Adjustments: | |||||||||||||
| Intangible asset amortization | — | — | — | — | (154,883) | — | — | ||||||
| Share-based compensation expense | (4,212) | 0.5 | (35,268) | (16,635) | — | — | — | ||||||
| Non-cash interest expense | — | — | — | — | — | (6,062) | — | ||||||
| Acquisition accounting inventory fair value step-up | (30,822) | 3.2 | — | — | — | — | — | ||||||
| Income tax effect of above adjustments | — | — | — | — | — | — | 54,554 | ||||||
| Total of non-GAAP adjustments | (35,034) | 3.7 | (35,268) | (16,635) | (154,883) | (6,062) | 54,554 | ||||||
| Non-GAAP Adjusted | $ 67,119 | 92.8 % | $ 273,042 | $ 217,767 | $ — | $ 65,435 | $ 7,378 |
| JAZZ PHARMACEUTICALS PLC | |||||||||||||||
| RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION | |||||||||||||||
| CERTAIN LINE ITEMS - FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2024 AND 2023 | |||||||||||||||
| (In thousands, except percentages) | |||||||||||||||
| (Unaudited) | |||||||||||||||
| Nine months ended September 30, 2024 | |||||||||||||||
| Cost of product sales | Gross margin | Selling, general and administrative | Research and development | Intangible asset amortization | Acquired IPR&D | Interest expense, net | Income tax expense (benefit) | ||||||||
| GAAP Reported | $ 317,000 | 88.7 % | $ 1,016,007 | $ 643,500 | $ 468,410 | $ 10,000 | $ 186,841 | $ (33,517) | |||||||
| Non-GAAP Adjustments: | |||||||||||||||
| Intangible asset amortization | — | — | — | — | (468,410) | — | — | — | |||||||
| Share-based compensation expense | (10,375) | 0.4 | (112,450) | (55,030) | — | — | — | — | |||||||
| Non-cash interest expense | — | — | — | — | — | — | (15,892) | — | |||||||
| Acquisition accounting inventory fair value step-up | (97,220) | 3.4 | — | — | — | — | — | — | |||||||
| Income tax effect of above adjustments | — | — | — | — | — | — | — | 164,516 | |||||||
| Total of non-GAAP adjustments | (107,595) | 3.8 | (112,450) | (55,030) | (468,410) | — | (15,892) | 164,516 | |||||||
| Non-GAAP Adjusted | $ 209,405 | 92.5 % | $ 903,557 | $ 588,470 | $ — | $ 10,000 | $ 170,949 | $ 130,999 | |||||||
| Nine months ended September 30, 2023 | |||||||||||||||
| Cost of product sales | Gross margin | Selling, general and administrative | Research and development | Intangible asset amortization | Acquired IPR&D | Interest expense, net | Income tax expense (benefit) | ||||||||
| GAAP Reported | $ 328,334 | 88.1 % | $ 947,071 | $ 633,050 | $ 456,731 | $ 1,000 | $ 219,114 | $ (86,823) | |||||||
| Non-GAAP Adjustments: | |||||||||||||||
| Intangible asset amortization | — | — | — | — | (456,731) | — | — | — | |||||||
| Share-based compensation expense | (11,399) | 0.4 | (113,155) | (49,346) | — | — | — | — | |||||||
| Other costs | — | — | (23,488) | — | — | — | — | — | |||||||
| Non-cash interest expense | — | — | — | — | — | — | (16,255) | — | |||||||
| Acquisition accounting inventory fair value step-up | (119,094) | 4.4 | — | — | — | — | — | — | |||||||
| Income tax effect of above adjustments | — | — | — | — | — | — | — | 159,608 | |||||||
| Total of non-GAAP adjustments | (130,493) | 4.8 | (136,643) | (49,346) | (456,731) | — | (16,255) | 159,608 | |||||||
| Non-GAAP Adjusted | $ 197,841 | 92.9 % | $ 810,428 | $ 583,704 | $ — | $ 1,000 | $ 202,859 | $ 72,785 |
| JAZZ PHARMACEUTICALS PLC | |||
| RECONCILIATION OF GAAP TO NON-GAAP ADJUSTED 2024 NET INCOME AND DILUTED EPS GUIDANCE | |||
| (In millions, except per share amounts) | |||
| (Unaudited) | |||
| Net Income | Diluted EPS | ||
| GAAP guidance | $430 - $550 | $6.70 - $8.50 | |
| Intangible asset amortization | 605 - 645 | 9.10 - 9.85 | |
| Acquisition accounting inventory fair value step-up | 125 - 145 | 1.90 - 2.20 | |
| Share-based compensation expense | 235 - 255 | 3.55 - 3.90 | |
| Non-cash interest expense | 20 - 30 | 0.30 - 0.45 | |
| Income tax effect of above adjustments | (210) - (220) | (3.15) - (3.35) | |
| Non-GAAP guidance | $1,275 - $1,350 | $19.50 - $20.60 | |
| Weighted-average ordinary shares used in per share calculations - GAAP and non-GAAP | 66 |
Investors: Andrea N. Flynn , Ph.D. Vice President, Head, Investor Relations Jazz Pharmaceuticals plc [email protected] Ireland +353 1 634 3211 U.S. +1 650 496 2717
Media: Kristin Bhavnani Head of Global Corporate Communications Jazz Pharmaceuticals plc [email protected] Ireland +353 1 637 2141 U.S. +1 215 867 4948
